Regulatory Focus™ > News Articles > FDA Clears Mayo Clinic to Manufacture PET Drug

FDA Clears Mayo Clinic to Manufacture PET Drug

Posted 12 September 2012 | By Alexander Gaffney, RAC 

Regulators with the US Food and Drug Administration (FDA) have approved the manufacture of an existing positron emission tomography (PET) drug for use at a new facility, the agency has announced.

The drug, Choline C 11 Injection, is used to help detect the presence of recurrent prostate cancer. The drug is administered to patients intravenously, and is specifically indicated for patients whose blood prostate specific antigen (PSA) levels have risen despite earlier treatment.

The manufacture of the drug is difficult, FDA explained, and its 12 September approval notice only allows its manufacture at a single facility, owned by the Minnesota-based Mayo Clinic. The drug must also be administered to patients shortly after its manufacture, making large-scale manufacturing difficult, and necessitating FDA's case-by-case approval basis.

Though the drug has been used in the past for the same purpose, under the terms of the 1997 FDA Modernization Act, companies needed to file new drug applications (NDAs) for any existing PET drug to ensure they conformed with good manufacturing practices. FDA delayed the implementation of the requirement until 12 June 2012, and its approval of the Mayo Clinic makes it the first facility approved to market Choline C 11.

"While PET imaging with Choline C 11 Injection has been performed at a few facilities over the past several years, none of these facilities were approved by the FDA to manufacture the agent," FDA explained. "The FDA's approval of Choline C 11 Injection at the Mayo Clinic provides assurance to patients and health care professionals they are using a product that is safe, effective, and produced according to current good manufacturing practices."


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe